Hepatitis C virus (HCV) represents the major etiologic agent of blood-borne and sporadic non-A, non-B hepatitis. The link between HCV chronic infections with liver cirrhosis and hepatocellular carcinoma makes HCV a significant world-wide health problem.
Two basic tests for HCV are predominantly used for diagnosis of HCV infection: 1) PCR based assays; and 2) serological detection of antibodies. Serological testing for HCV antibodies (Ab) represents the standard method for the detection of HCV infection in a human subject. Early serological assays, however, suffered from significant drawbacks in poor sensitivity thereby producing unacceptably high false negative results. Although the sensitivity and specificity of the second and third generation enzyme immunoassays were significantly improved, the existence of a “window period” from initiation of HCV infection to seroconversion generates an opportunity for false negative results. This period varies from 2 months in immunocompetent subjects to 6-12 months in immunodeficient patients.
HCV has a single strand positive sense RNA genome of approximately 9,400 nucleotides in length. HCV infections, therefore, are also detectable using nucleic acid-based technologies based on the polymerase chain reaction (PCR). In addition to PCR based screening, the combination of PCR screening with serological testing has been proposed. This combination approach decreases the risk of HCV transmission from infected donors during the “window period” due to the PCR approach being capable of detection prior to seroconversion. Unfortunately, genetic testing presents considerable challenges to public health and clinical laboratories owing to requirements for specific equipment and sensitivity to cross-contamination.
As such, there exists a need for compositions and methods that can be used as aids in screening for identification and development of HCV infection a subject.